Hospitals employ multiple strategies to prevent and/or reduce infections associated with the use percutaneous medical devices, such as antiseptic preparation of insertion sites, including the initial application of topical anti-microbial solutions such as alcohol or iodine to the insertion sites is known. A further topical ointment after insertion of the device, such as an ointment containing neomycin, polymyxin and bactracin, has been shown to prevent catheter colonization/infection.
There have also been attempts to attach a cuff to the catheters, with an anti-microbial agent impregnated in the cuff. A commercially available product sold under the trade mark BIOPATCH® is applied around percutaneous devices to prevent localized infection at the insertion site. This product is a foam material that contains an antimicrobial agent chlorhexidine gluconate. Efforts to coat the catheters with anti-microbial agents are known.
Recent efforts to use a transparent film dressing to allow a visual check on the insertion site is known see for instance U.S. Pat. No. 5,372,589, issued Dec. 13, 1994 to Davis.
In addition to infection control, there is a need for percutaneous devices to remain securely in place. Securement device are known, such as U.S. Pat. No. 3,918,446, issued Nov. 11, 1975 to Buttaravoli. The device has an upper and a lower pad, between which the intravenous device is fixed. Since the function of the device is to secure the device to the body, there is a teaching to provide an adhesive material to the bottom of lower pad, and to the bottom of the top pad. There is a mention of providing the adhesive with an antibacterial agent. The device of this patent teaches including a slit in the bottom pad of the dressing, which lies below the intravenous needle or catheter when the device is in place, allowing the intravenous device to remain in contact with the skin, and therefore limiting the infection control of the device.
U.S. Pat. No. 5,833,665 issued to Matthew Bootman et al. is directed to a wound dressing for percutaneous catheters that is comprised of a crosslinked polymer containing a bioactive agent. It discloses a radial slit that is made in the device so that it can be deployed over an already placed catheter. It also discloses and claims the use of adhesives for securing the device.
Tegaderm™-CHG is a commercial device designed to reduce the incidence of CRBSI, with the CHG being the anti-microbial agent. The CHG is intended to elute from a pad that is transparent and covered with an adhesive bandage layer. The device fails to provide 360 degree coverage around the insertion site, and thereby cannot optimally reduce the potential for CRBSI. The CHG eluting portion of the device is not placed underneath the catheter which may further limit its effectiveness. A number of other patents are teaching various single slit embodiments, including U.S. Pat. No. 7,137,968; U.S. Pat. No. 5,554,106; U.S. Pat. No. 6,765,122; U.S. Pat. No. 7,723,559; U.S. Pat. No. 4,915,694; U.S. Pat. No. 5,968,000; and U.S. Pat. No. 5,620,419.
It is an object of the present invention to provide a catheter-securing and drug delivery device which is easily applied and is made of a polymer which serves as a delivery vehicle for controlled release of a bioactive agent entirely around a percutaneous wound site.
These and other objects of the invention will be apparent from the following description and appended claims, and from practice of the invention.